Research Studies

The Department of Obstetrics and Gynecology engages in ongoing research studies, including publications and landmark articles.

Current & Ongoing Studies

American Heart Association Congenital Heart Defects Study

About 3 in every 100 babies is born with a birth defect of some type. Congenital heart defects (CHDs) are among the most common of these, affecting almost 40,000 babies every year. While many of these babies do well after birth, some have very serious problems. We can sometimes be certain that a baby will, or will not, have problems after birth. Sometimes, however, it is not possible to be certain before birth how a baby will do. We believe that the placenta (which connects the baby to the inside of its mother’s uterus), interactions between the genes of the parents and baby, and the family’s environment may all play a part both in the cause, or causes, of CHDs and in determining how a baby will do after he or she is born. The purpose of this study is to learn more about how the placenta, genes, and environment contribute both to the cause of CHDs and to how babies with CHDs do after they are born.

Certolizumab to Prevent Pregnancy Complications in High-Risk Patients with APS or SLE

Pregnancies in patients with antiphospholipid syndrome who have a lupus anticoagulant have a high likelihood of ending in fetal death or very premature delivery because of poor placental development and preeclampsia. At present, there is no effective treatment for women with these high-risk pregnancies, but work in an animal model that mimics this human condition shows that blockade of TNF- alpha, a pivotal mediator of inflammation, prevents adverse outcomes. The IMPACT trial aims to determine whether treatment during pregnancy with certolizumab, a TNF-alpha inhibitor that does not cross the placenta, reduces the rate of poor pregnancy outcomes in women with clinical antiphospholipid syndrome. If successful, it will provide a new approach to protecting pregnancies in women with antiphospholipid syndrome and a rationale for trials of TNF-alpha blockade in women with other conditions who are at risk for preeclampsia or placental insufficiency.

Puerperal Group A Streptococcal Sepsis: Prospective Case Registry

 Group A streptococcus is an uncommon but serious cause of uterine infections after delivery.  Most women with this infection have a mild uterine infection that resolves with antibiotics.  Other women become very ill with a life-threatening infection.  We are interested in determining why some women get better quickly, while others are severely affected. The immune system is responsible for fighting infections. We suspect that the immune system may function differently in women who have had a severe group A streptococcus uterine infection after childbirth. We would like to look at blood or saliva samples from women with a previous history of a group A streptococcus uterine infection to attempt to answer this question.

Evaluation of the Effectiveness, Safety & Tolerability of LevoCept (Levonorgestrel-Releasing Intrauterine System) for Long-Acting Reversible Contraception

To evaluate the effectiveness, device placement, safety and tolerability of LevoCept to support commencing a Phase III Clinical Study. Evaluation of the Efficacy and Safety of LevoCept

A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone

The objectives of this study are to evaluate the contraceptive efficacy, vaginal bleeding pattern (cycle control), and the general safety and acceptability of the 15 mg estetrol (E4)/3 mg drospirenone (DRSP) combination in healthy women aged 16 to 50 years. E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - US/CA Study

Understanding Placenta Accreta: Improving Diagnostic Accuracy, Evaluating Optimal Management Strategies & Assessment of Long-Term Outcomes

Placenta accreta occurs when the placenta invades too deeply into, or through, the wall of the uterus. Its frequency increases dramatically in pregnant women who have had increasing numbers of cesarean deliveries. This study is collecting placental and uterine muscle samples as well as maternal blood samples in affected women and is following these women after pregnancy for assessment of long-term outcomes.

Markers for Adverse Pregnancy Outcome: Universal Sample Collection

This protocol is collecting blood and DNA samples on mothers and babies from normal and complicated pregnancies.

Prospective Stillbirth Collection: A Database & Tissue Banking Study

This project is collecting maternal and fetal DNA as well as placental samples in women who experience a stillbirth and correlating laboratory findings with clinical histories.

RAPID EC – RCT Assessing Pregnancy with Intrauterine Devices for Emergency Contraception

This study offers women who have had recent unprotected intercourse and who want an IUD to receive either a copper IUD or hormonal IUD. Women involved in the study do have a 50:50 chance of getting each IUD, like flipping a coin. RAPID EC - Rct Assessing Pregnancy With Intrauterine Devices for EC

Highly Effective Reversible Contraceptive Initiative—Salt Lake (HER-SLC)

HER Salt Lake follows women starting a new method of contraception for up to three years to study impacts on their social lives including education, finances, and sexual satisfaction. HER Salt Lake Initiative

Chronic Hypertension & Pregnancy (CHAP)

This study is comparing is enrolling pregnant women with non-severe chronic hypertension and randomizing them to either primary treatment with labetalol or nifedipine or to ACOG standard treatment (antihypertensive medication only with development of severe hypertension). The primary outcome is a composite of maternal and fetal-neonatal outcomes. This study is funded by the NICHD as a multicenter R01 awarded to the University of Alabama at Birmingham. Chronic Hypertension and Pregnancy (CHAP) Project

A Randomized Trial of Pessary & Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)

Women pregnant with twins between 16 0/7 – 23 6/7 weeks who are found to have a short cervix (<30 mm) on vaginal ultrasound and who agree to participate would be randomized to either an Arabin pessary, vaginal progesterone or a vaginal placebo. The primary outcome is preterm birth <35 weeks gestation. This study is funded by the NICHD MFMU Network. A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

A Randomized Trial of Pessary in Singleton Pregnancies with a Short Cervix (TOPS)

Women pregnant with singleton pregnancies between 16 0/7 – 23 6/7 weeks who are found to have a short cervix (<20 mm) on vaginal ultrasound and who agree to participate would be randomized to either an Arabin pessary or standard care. The primary outcome is preterm birth <37 weeks gestation. This study is funded by the NICHD MFMU Network. A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix